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ST-2; a Non-invasive Fibrosis Marker for Chronic Hepatitis B

Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01633554
Collaborator
(none)
95
Enrollment
1
Location
20
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

IL-33 is a recently identified number of the IL-1 family. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    ST-2 is an IL-1 receptor family member and exists in both a membrane-bound isoform and a soluble (sST2) isoform. It has a functional ligand (Interleukin-33) and via ST-2/IL-33 inflammation and immunity is regulated. Hepatic over-expression of IL-33 has been recently linked to liver fibrosis. ST-2 exerts pro-inflammatory effects of IL-33. We aimed to determine ability of ST2 to predict fibrosis in chronic hepatitis B.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    95 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Ability of Prediction of Fibrosis for ST-2 as a Non-invasive Marker in Chronic Hepatitis B
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Jul 1, 2012
    Anticipated Study Completion Date :
    Sep 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Hepatitis B Group

    Patients with chronic hepatitis B
    Cirrhosis

    Patients with liver cirrhosis
    Control Group

    Control Group: Healthy Volunteers

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Clinical diagnosis of chronic hepatitis B or liver cirrhosis
      Exclusion Criteria:
      • Accompanying chronic inflammatory disease

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Türkiye Yüksek İhtisas Education and research Hospital Altındağ Ankara Turkey 06100

      Sponsors and Collaborators

      • Turkiye Yuksek Ihtisas Education and Research Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      İsmail Hakkı KALKAN, MD, Turkiye Yuksek Ihtisas Education and Research Hospital
      ClinicalTrials.gov Identifier:
      NCT01633554
      Other Study ID Numbers:
      • 24190708
      • IKalkan24190708
      First Posted:
      Jul 4, 2012
      Last Update Posted:
      Jul 4, 2012
      Last Verified:
      Jul 1, 2012
      Keywords provided by İsmail Hakkı KALKAN, MD, Turkiye Yuksek Ihtisas Education and Research Hospital
      ST-2, IL-33, prediction, fibrosis, hepatitis B
      Additional relevant MeSH terms:
      Hepatitis B
      Hepatitis B, Chronic
      Hepatitis
      Liver Diseases
      Fibrosis

      Study Results

      No Results Posted as of Jul 4, 2012